FDA set to review Sanofi’s isatuximab for multiple myeloma
Multiple myeloma is the second most common hematologic malignancy, affecting more than 138,0002 people worldwide.
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Tag: Biologics License Application
Novartis’ wet AMD drug gets FDA filing
The decision is primarily based on Phase III data from the HAWK and HARRIER trials.
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FDA thumbs up for Esperoct in haemophilia A
Novo Nordisk has received US approval for haemophilia A drug Esperoct.
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- Kahimmune Therapeutics enters licensing agreement with Gustave Roussy and SATT Paris-Saclay
- IBSA UK&I launches Perovial for the treatment of acute Peyronie’s disease
- En Carta Diagnostics’ EC Pocket Lyme test receives FDA Breakthrough Device Designation
- ALK’s EURneffy receives positive CHMP opinion for emergency anaphylaxis treatment in children
- CERo reports encouraging early data from phase 1 trial of CER‑1236
